Statistics & PAT Expert

Major Accountabilities

Manufacturing Excellence – Statistics & PAT:

• Process Validation and Transfers

• Statistical analysis of process validation data for demonstrating validity and equivalence

• Contribute to risk assessments, e.g. FMEA or risk matrix.

• Planning and evaluation of Design of Experiments (DoEs) in the frame of the Novartis Quality by Design validation strategy.

• Trending analysis in the frame of Ongoing Process Verification.

• Implementation and application of Statistical Process Control principles, e.g. control charts, and other pattern recognition techniques.

• Support the compilation of Annual Product Review (APR)/Product Quality Reviews(PQRs).

• Facilitate and enable (multivariate) process monitoring and control principles, e.g. by Multivariate data analysis (MVDA).

• Review of stability data and definition of Internal Release Limits (IRL)

• Support critical root cause Investigation.

• Support the analysis of complex data sets to facilitate Rapid Root Cause Investigation (rRCI).

• Accountable for providing meaningful statistical conclusions.

• Analytical method validation and transfer, in particular Process Analytical Technology (PAT) methods.

• Support the design of an analytical robustness test, e.g. by means of DoE

• Statistical assessment of method validation data and technology and process transfer across sites.

• Development and validation of multivariate models for online PAT methods.

• Enable Process improvement initiatives (also in alignment with operational excellence organization and methodologies (e.g. IQP, Six Sigma, Lean Manufacturing):

• Capability and stability assessments.

• Hypothesis testing

• Models for facilitating process improvements, e.g. DoE, MVDA, etc.

Training:

• Enable the Site to have the necessary competencies in advanced applied statistical tools, cross-functionally (MS&T, manufacturing, QA, QC, operational excellence, ...) by designing and delivering training on available tools and how to use them in practice, and providing ongoing coaching.

• Instruct how to collect (e.g. sampling plans that are statistically meaningful), set up, and interpret data sets and statistical results highlighting constraints and limitations.

• Interacts with internal and external Reg bodies and Health Authorities, as well as internal functions (development organization, RegCMC, QA/QC, Engineering, global MS&T) as appropriate (e.g. during inspections, investigations etc.) in statistical aspects of data analysis and rationales.

Key Performance Indicators

• Success rate of Health Authorities' Inspections

• Successful PAT transfer and implementation in the DSS site.

• Technology transfers and new product launches on time, right first time.

• Technical reports executed on time and with the right expectations.

• Applied statistics training in place and executed.

Specific Professional Competencies

• cGMP and Good Documentation Practices

• Root Cause Analysis (RCA)

• Corrective Action and Preventive Action

• Statistical Process Monitoring

• Knowledgeable on Effectiveness Checks

• Continuous Process Improvement

• Drug Substance Manufacturing

• Process Design and Control

• Gap Assessment and Risk Analysis

• Complaints and OOXs Handling

• Technology Transfer

• Report writing

• Data Analytics

• Project Management

Ideal Background

Education:      

• Masters in Statistics, Mathematics, Chemical Engineering, or its equivalent education is desirable.                             

Languages:  

• English (oral and written).

Experiences:

• Minimum 10 years of experience in MS&T or in the manufacturing of Biologics in large molecules.

• At least 5 years of experience in MS&T or Manufacturing operations.

• Proven process understanding (Pharma, GMP, Regulatory aspects).

• Proven experience in applied statistics is a must, e.g., in the field of DOEs and multivariate data analysis.

• Experience in the following software and tools is a plus: SAS, R, Python, Minitab, SIMCA-P+, Modde, JMP, SPSS

Good communication, presentation, and interpersonal skills.